Director Toxicology

Location: Remote/home-based in Canada, the United Kingdom, or the United States, with listed locations in Mississauga, London, and California.

Base salary for US-based candidates: $204,000–$306,000 annually, plus potential bonus, equity, and benefits.

Company

hirify.global is a global biopharmaceutical company developing medicines for serious diseases, with a portfolio spanning sleep disorders, epilepsy, oncology, and neuroscience.

What you will do

• Manage global nonclinical regulatory and investigative toxicology for assigned drug development programs.
• Design, monitor, review, and finalize GLP and non-GLP toxicology studies conducted by external CROs.
• Analyze toxicology data, define PK/PD and PK/toxicity correlations, and coordinate study-report delivery.
• Represent Toxicology in cross-functional early-development and drug-development teams.
• Draft nonclinical sections for IND, CTA, NDA, BLA, and related regulatory documents.
• Partner with Regulatory, Quality, Clinical, CMC, Product Quality, Drug Safety, and Medical Affairs functions.

Requirements

• Ph.D. in Toxicology, Pharmacology, Pathology, Biochemistry, Biology, or a related field, with extensive pharmaceutical drug-development toxicology experience.
• Extensive experience with small and large molecules; oncology and CNS experience is preferred.
• Experience outsourcing and monitoring toxicology studies, managing CROs, and reviewing scientific reports.
• Strong knowledge of FDA, EMA, ICH guidance, and GLP regulations.
• Experience authoring nonclinical sections of IND, CTA, BLA, NDA, or related submissions and preparing responses to regulatory questions.
• Strong scientific writing, communication, multidisciplinary data-integration, and cross-functional leadership skills.

Nice to have

• Board certification such as DABT or ERT, or board eligibility with intent to complete certification.
• Discovery Toxicology experience in early, non-IND-enabling development.

Culture & Benefits

• Work in a fast-paced, hands-on, multi-tasked biopharmaceutical environment.
• Flexible remote/home-based work arrangement for listed countries.
• Potential annual cash bonus or incentive compensation.
• Potential long-term equity incentive grants.
• Medical, dental, and vision insurance, 401(k) retirement savings, and flexible paid vacation for eligible US-based employees.